InvestBio News
Open in Telegram
Аlerts on clinical catalysts & market moves for NASDAQ/NYSE biotech stocks. feedback : @bio_feedback_bot
Show more990
Subscribers
No data24 hours
-27 days
No data30 days
Data loading in progress...
Similar Channels
![PPP Onaryx [Dead]](https://cdn.tlmtr.io/_next/image?url=https%3A%2F%2Fimg.tlmtr.io%2Fc%2F1fRI2t%2F5467503663300850254%3Fty%3Dx&w=96&q=75){kind=small}
Tags Cloud
Incoming and Outgoing Mentions
---
---
---
---
---
---
Attracting Subscribers
September '26
September '26
+2
in 0 channels
August '26
+15
in 0 channels
Get PRO
July '26
+14
in 0 channels
Get PRO
June '26
+7
in 0 channels
Get PRO
May '26
+23
in 0 channels
Get PRO
April '26
+15
in 0 channels
Get PRO
March '26
+9
in 0 channels
Get PRO
February '26
+12
in 0 channels
Get PRO
January '26
+32
in 0 channels
Get PRO
December '25
+23
in 0 channels
Get PRO
November '25
+16
in 0 channels
Get PRO
October '25
+5
in 0 channels
Get PRO
September '25
+7
in 0 channels
Get PRO
August '25
+3
in 0 channels
Get PRO
July '25
+17
in 0 channels
Get PRO
June '25
+7
in 0 channels
Get PRO
May '25
+13
in 0 channels
Get PRO
April '25
+20
in 0 channels
Get PRO
March '25
+15
in 0 channels
Get PRO
February '25
+27
in 0 channels
Get PRO
January '25
+23
in 0 channels
Get PRO
December '24
+16
in 0 channels
Get PRO
November '24
+21
in 0 channels
Get PRO
October '24
+31
in 0 channels
Get PRO
September '24
+23
in 0 channels
Get PRO
August '24
+22
in 0 channels
Get PRO
July '24
+25
in 0 channels
Get PRO
June '24
+16
in 0 channels
Get PRO
May '24
+11
in 0 channels
Get PRO
April '24
+11
in 0 channels
Get PRO
March '24
+13
in 0 channels
Get PRO
February '24
+24
in 0 channels
Get PRO
January '24
+39
in 0 channels
Get PRO
December '23
+27
in 0 channels
Get PRO
November '23
+5
in 0 channels
Get PRO
October '23
+4
in 0 channels
Get PRO
September '23
+16
in 0 channels
Get PRO
August '23
+40
in 0 channels
Get PRO
July '23
+9
in 0 channels
Get PRO
June '23
+21
in 0 channels
Get PRO
May '23
+7
in 0 channels
Get PRO
April '23
+4
in 0 channels
Get PRO
March '23
+14
in 0 channels
Get PRO
February '23
+13
in 0 channels
Get PRO
January '23
+58
in 0 channels
Get PRO
December '22
+45
in 0 channels
Get PRO
November '22
+13
in 0 channels
Get PRO
October '22
+6
in 0 channels
Get PRO
September '22
+59
in 0 channels
Get PRO
August '22
+72
in 0 channels
Get PRO
July '22
+37
in 0 channels
Get PRO
June '22
+37
in 0 channels
Get PRO
May '22
+16
in 0 channels
Get PRO
April '22
+44
in 0 channels
Get PRO
March '22
+5
in 0 channels
Get PRO
February '22
+19
in 0 channels
Get PRO
January '22
+54
in 0 channels
Get PRO
December '21
+42
in 0 channels
Get PRO
November '21
+111
in 0 channels
Get PRO
October '21
+153
in 0 channels
Get PRO
September '21
+85
in 0 channels
Get PRO
August '21
+106
in 0 channels
Get PRO
July '21
+197
in 0 channels
Get PRO
June '21
+164
in 0 channels
Get PRO
May '21
+88
in 0 channels
Get PRO
April '21
+346
in 0 channels
Get PRO
March '21
+782
in 0 channels
| Date | Subscriber Growth | Mentions | Channels | |
| 10 September | 0 | |||
| 09 September | 0 | |||
| 08 September | 0 | |||
| 07 September | +1 | |||
| 06 September | 0 | |||
| 05 September | 0 | |||
| 04 September | 0 | |||
| 03 September | 0 | |||
| 02 September | +1 | |||
| 01 September | 0 |
Channel Posts
| 2 |  No text... | 27 |
| 3 | 📰 Pre-Market Biotech Stock
〰〰〰〰〰〰〰〰〰〰〰〰
---------------------------------------- * Tenon Medical (TNON):* Repaid about $5.16M of senior convertible notes early, removing potential discounted-share conversion overhang. * AEON Biopharma (AEON):* ABP-450 showed degradation patterns comparable to BOTOX, supporting its planned 351(k) biosimilar strategy. * BioLineRx (BLRX):* Will present GLIX1 glioblastoma preclinical data and its Phase 1/2a trial design at EANO 2026. * *NeuroSense (NRSN):* Announced a 1-for-20 reverse split, with post-split trading expected September 14. * CDT Equity (CDT):* Highlighted Sarborg’s neuropsychiatric drug-discovery platform and its 22.7% ownership stake. * *Radiopharm (RADX):* Phase 1 RAD301 data showed favorable safety and tumor uptake in pancreatic cancer, supporting advancement toward Phase 2 imaging. Premarket Biotech Updates -------------------------
Tenon Medical (NASDAQ: $TNON) shares surged premarket after the company fully repaid about $5.16 million of senior convertible notes ahead of maturity, strengthening its balance sheet and removing potential discounted share-conversion overhang as it continues commercializing its Catamaran SI Joint Fusion System.
AEON Biopharma (NYSE: $AEON) reported pilot forced-degradation data showing ABP-450 had comparable thermal potency-loss and oxidative-stress patterns to BOTOX, adding analytical support for its planned 351(k) biosimilar pathway, though formal conclusions depend on a multi-lot comparability study expected to begin in H1 2027.
CDT Equity (NASDAQ: $CDT) highlighted minority-owned Sarborg’s application of patented Signature Intelligence and quantum computing models to neuropsychiatric drug discovery, including disease signatures for depression, bipolar disorder, anxiety and schizophrenia, while CDT’s 22.7% Sarborg stake is marked against a recent financing implying an approximately $709 million fully diluted valuation.
NeuroSense Therapeutics (NASDAQ: $NRSN) will implement a 1-for-20 reverse share split with post-split Nasdaq trading expected September 14, 2026, reducing issued and outstanding ordinary shares from about 37.9 million to 1.9 million while leaving authorized share capital unchanged and proportionately adjusting warrants and options.
BioLineRx (NASDAQ: $BLRX) and Hemispherian will present GLIX1 preclinical glioblastoma data and Phase 1/2a trial design at EANO 2026, highlighting brain penetration, dose-dependent tumor inhibition and survival benefit in orthotopic models including temozolomide-resistant disease, while an actively enrolling first-in-human recurrent or progressive high-grade glioma study supports BioLineRx’s oncology pipeline expansion beyond APHEXDA.
Radiopharm Theranostics (NASDAQ: $RADX) reported Phase 1 RAD301 imaging data in pancreatic ductal adenocarcinoma showing favorable safety, biodistribution and significant tumor uptake in evaluable metastatic lesions, supporting αvβ6-integrin as a tumor-specific imaging target and continued development toward a Phase 2 imaging trial with potential future theranostic applications.
#AEON #BLRX #CDT #NRSN #RADX #TNON | 27 |
| 4 |  No text... | 36 |
| 5 |  No text... | 33 |
| 6 | ⬇ continuation ⬇
Company: $MNKD - MannKind Corporation
Drug: ROSE-010 (Obesity)
Stage: Phase 2
Catalyst: Phase 2 collaboration with Rose Pharma, noted September 9, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $KZIA - Kazia Therapeutics Limited
Drug: Paxalisib in combination with gemcitabine - (PNOC035) (Recurrent or progressive atypical teratoid/rhabdoid tumor (AT/RT).)
Stage: Phase 2
Catalyst: Phase 2 dosing commenced, noted September 9, 2026.
〰〰〰〰〰〰〰〰〰〰〰
#KZIA #MNKD | 31 |
| 7 | 💊 Pipeline updates
〰〰〰〰〰〰〰〰〰〰〰
Company: $XOMA - XOMA Royalty Corporation,
Drug: LGND - Ligand Pharmaceuticals Incorporated, ( RZLT - Rezolute Inc.)
Stage: Phase 3
Catalyst: Phase 3 study reports that the FDA continues to review additional datasets after the study missed its primary endpoint, noted September 9, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $PYXS - Pyxis Oncology Inc.
Drug: micvotabart pelidotin (PYX-201-101) - (MICVO) (Solid tumors)
Stage: Phase 2
Catalyst: Phase 1 monotherapy data in 2L+ recurrent/metastatic head and neck squamous cell carcinoma showed 36% confirmed ORR, 94% disease control, 6.2-month median progression-free survival and 79% 12-month OS probability, with no new safety signals and dose capping improving tolerability, supporting a planned EoP2 FDA meeting in Q1 2027 and Phase 3 Headliner initiation in mid-2027, noted September 9, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $MTVA - MetaVia Inc.
Drug: DA-1726 (non-alcoholic steatohepatitis and obesity)
Stage: Phase 1
Catalyst: Preclinical tissue-distribution data showed the highest exposure in adipose tissue, prolonged tissue retention through 144 hours, and minimal CNS penetration, noted September 9, 2026. Phase 1 part 3 completed successfully at the highest target doses of 48 mg and 64 mg, noted July 9, 2026. Phase 1 16- week topline data expected in 4Q 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $SER - Serina Therapeutics Inc.
Drug: SER-252 (POZ-apomorphine) in combination with enFuse (Parkinson’s disease)
Stage: Phase 1b
Catalyst: Independent Safety Monitoring Committee recommends advancement to Cohort 2 following blinded review of Cohort 1 safety and tolerability data, noted September 9, 2026. Phase 1b Cohort 1 enrollment completed, noted July 23, 2026. Phase 1b Social Anxiety Disorder study arm topline data due in 1H 2027.
〰〰〰〰〰〰〰〰〰〰〰
Company: $TYRA - Tyra Biosciences Inc.
Drug: TYRA-300 - (SURF302) (Non-Muscle Invasive Bladder Cancer)
Stage: Phase 2
Catalyst: Phase 2 initial data showed chronic-dosing tolerability, with no Grade 3 treatment-related adverse events at 60 mg once daily and 79% ORR with 64% best overall complete response across marker-lesion patients, as of September 9, 2026. Phase 2 study dosing commenced, noted June 30, 2025.
〰〰〰〰〰〰〰〰〰〰〰
Company: $IRD - Opus Genetics Inc.
Drug: OPGx-BEST1 - (BIRD-1) (Bestrophin-1 (BEST1)-related IRD.)
Stage: Phase 1/2
Catalyst: Phase 1/2 Cohort 2 over-enrolled, with dosing expected to be completed in 4Q 2026 and topline 3-month data expected in 2Q 2027. Phase 1/2 3-month low-dose data in BEST1-related retinal disease showing no serious adverse events, dose-limiting toxicities or intraocular inflammation across five treated patients, with early microperimetry signals in 75% of evaluable participants and pivotal dosing planned in 2027 after Phase 3/commercial manufacturing readiness, noted September 9, 2026. Phase 1/2 initial from sentinel participant showed OPGx-BEST1 was well tolerated with no ocular inflammation, treatment-related adverse events, or dose-limiting toxicities at three months, noted February 27, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $RZLT - Rezolute Inc.
Drug: Ersodetug (RZ358) - (upLIFT) (Hypoglycemia caused by tumor Congenital hyperinsulinism)
Stage: Phase 3
Catalyst: Phase 3 50% enrollment completed with 6/8 already met its primary endpoint, noted June 2, 2026. Phase 3 topline data expected in late 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $PRQR - ProQR Therapeutics N.V.
Drug: AX-0811 (NTCP-targeting RNA editing oligonucleotide generated)
Stage: Phase 1
Catalyst: Phase 1 dosing commenced, noted September 9, 2026. Phase 1 data expected in early January 2027. Clinical Trial Applications submitted in mid-2026 for AX-0811.
〰〰〰〰〰〰〰〰〰〰〰
#IRD #MTVA #PRQR #PYXS #RZLT #SER #TYRA #XOMA | 16 |
| 8 | ⬇ continuation ⬇
EoCene (NASDAQ: $EOCN), formerly Galmed Pharmaceuticals (NASDAQ: $GLMD), rebranded to reflect a broader GI-focused medtech and biopharma strategy following the Colospan acquisition, will begin Nasdaq trading under EOCN on September 10, 2026, regained minimum bid compliance and terminated its Yorkville standby equity purchase agreement after raising about $7.3 million under the facility. Shares closed up 21% at $4.63.
#EOCN #GLMD | 12 |
| 9 | 📰 Daily Biotech Stock Updates
〰〰〰〰〰〰〰〰〰〰〰〰
----------------------------------------- * Opus Genetics (IRD) +32%:* Wedbush raised its target to $13, citing stronger confidence in OPGx-BEST1 and FDA alignment on pivotal endpoints. * EoCene (EOCN) +21%:* Former Galmed Pharmaceuticals rebranded and begins Nasdaq trading under EOCN on September 10. * *bioAffinity (BIAF) +18%:* Shares advanced after regaining Nasdaq minimum bid-price compliance. * Tyra Biosciences (TYRA) -18%:* Phase 2 SURF302 showed a 79% ORR and 64% best-overall complete response with dabogratinib in FGFR3-altered Non-Muscle Invasive Bladder Cancer. * Evommune (EVMN) -17%:* Phase 2b EVO756 missed primary and key secondary endpoints in atopic dermatitis, ending the AD program. * Pyxis Oncology (PYXS) -13%:* Phase 1 MICVO posted a 36% confirmed ORR in head and neck squamous cell carcinoma; a Phase 3 study is planned for mid-2027. Daily Biotech Updates ---------------------
Opus Genetics (NASDAQ: $IRD) Wedbush reiterated Buy and raised its price target to $13 from $10, citing higher confidence in OPGx-BEST1 after FDA alignment on pivotal microperimetry endpoints and an estimated probability-of-success increase to 50% from 35%, while Cohort 2 progress supports a planned pivotal trial start in 2027. Shares closed up 32% at $5.73.
bioAffinity Technologies (NASDAQ: $BIAF) shares rose 18% to $10.5 after Nasdaq bid-price compliance.
Tyra Biosciences (NASDAQ: $TYRA) released initial Phase 2 SURF302 data evaluating oral dabogratinib for FGFR3-altered low-grade intermediate-risk Non-Muscle Invasive Bladder Cancer, highlighting favorable chronic tolerability free from Grade 3 treatment-emergent side effects at 60 mg daily; with the 60 mg arm posting a 79% ORR and a 64% best-overall complete response in marker-lesion subjects to back a planned pivotal adjuvant submission, the company is adding a 70 mg dose cohort to test higher exposure levels in ablative settings. Shares closed down 18% at $22.01.
Pyxis Oncology (NASDAQ: $PYXS) reported updated Phase 1 results testing MICVO monotherapy in 2L+ recurrent or metastatic head and neck squamous cell carcinoma, highlighting a 36% confirmed ORR and 94% disease control rate, accompanied by a 6.2-month median progression-free survival alongside a 79% 12-month OS rate; supported by improved tolerability via dose capping with no new safety warnings, the business plans an End-of-Phase 2 FDA meeting in 1Q 2027 prior to initiating the Phase 3 Headliner study in mid-2027. Shares closed down 13% at $3.38.
Evommune (NYSE: $EVMN) reported Phase 2b data for EVO756 targeting moderate-to-severe atopic dermatitis, noting the study missed both primary and key secondary endpoints at Week 12 and leading to the discontinuation of the AD development program despite an uncompromised safety profile; going forward, the company will pivot its AD pipeline toward its primary IL-18BP fusion candidate EVO301 following positive Phase 2a proof-of-concept findings while continuing mid-stage development of EVO756 for migraine prevention. Shares fell 17% to $10.84.
Gossamer Bio (NASDAQ: $GOSS) announced a 1-for-80 reverse stock split scheduled to take effect on September 10, 2026, with split-adjusted trading beginning September 11 to satisfy Nasdaq minimum bid price requirements; alongside scaling down total authorized common shares to 50 million from 4.0 billion, the corporate restructuring proportionately recalibrates outstanding warrants, equity awards, and convertible notes while maintaining governance alignment rather than presenting new clinical updates. Shares closed down 11% at $0.16.
#BIAF #EVMN #GOSS #IRD #PYXS #TYRA | 22 |
| 10 |  No text... | 36 |
| 11 |  No text... | 35 |
| 12 | ⬇ continuation ⬇
Evommune (NYSE: $EVMN) revealed Phase 2b trial results for EVO756 in moderate-to-severe atopic dermatitis that failed to meet primary and secondary efficacy metrics at Week 12, prompting the termination of its AD program despite clean safety profiles; moving forward, the firm is redirecting its AD pipeline toward primary IL-18BP fusion construct EVO301 following supportive Phase 2a proof-of-concept outcomes while advancing EVO756 in mid-stage migraine prevention studies.
Serina Therapeutics (NYSE: $SER) revealed that an Independent Safety Monitoring Committee endorsed moving forward to Cohort 2 in its Phase 1b trial of SER-252 for Parkinson’s disease following a blinded review of initial cohort safety data; the positive recommendation supports ongoing dose expansion and further clinical progress for the POZ-platform based asset.
Adagene (NASDAQ: $ADAG) received a $2.0 million preclinical milestone payment from partner Exelixis tied to XB404, a SAFEbody-masked ADC hitting ROR1/2, alongside a supplemental fee for nominating a candidate in a separate masked ADC effort; the non-dilutive capital underscores active collaboration progress while offering further validation for the firm's masked antibody platform technology.
#ADAG #EVMN #SER | 34 |
| 13 | 📰 Pre-Market Biotech Stock
〰〰〰〰〰〰〰〰〰〰〰〰
--------------------------------------- * Tyra Biosciences (TYRA):* Phase 2 SURF302 showed a 79% ORR and 64% best-overall complete response with dabogratinib in FGFR3-altered Non-Muscle Invasive Bladder Cancer. * Evommune (EVMN):* Phase 2b EVO756 missed primary and secondary endpoints in atopic dermatitis, prompting termination of the AD program. * Pyxis Oncology (PYXS):* Phase 1 MICVO produced a 36% confirmed ORR and 94% disease control rate in recurrent/metastatic head and neck squamous cell carcinoma; Phase 3 is planned for 2027. * Opus Genetics (IRD):* Early Phase 1/2 OPGx-BEST1 data showed favorable safety and preliminary retinal efficacy signals. * Serina Therapeutics (SER):* Safety committee recommended advancing SER-252 into Cohort 2 of its Phase 1b Parkinson’s trial. * *bioAffinity (BIAF):* Regained Nasdaq minimum bid-price compliance, resolving its prior listing deficiency. * Tenon Medical (TNON):* Debt repayment ahead of maturity. Premarket Biotech Updates -------------------------
bioAffinity Technologies (NASDAQ: $BIAF) restored compliance with Nasdaq minimum bid price standards, resolving its listing deficiency following prior stock fluctuations; while eliminating immediate delisting risks, the corporate update centers on exchange governance rather than fresh clinical data, regulatory milestones, or funding events.
Tyra Biosciences (NASDAQ: $TYRA) disclosed preliminary Phase 2 SURF302 outcomes for oral dabogratinib in FGFR3-altered low-grade intermediate-risk Non-Muscle Invasive Bladder Cancer, demonstrating an encouraging chronic-dosing safety profile devoid of Grade 3 treatment-emergent adverse events at the 60 mg daily level; alongside a 79% ORR and 64% best-overall complete response within marker-lesion cohorts backing the 60 mg regimen for an upcoming registrational adjuvant pathway, the firm is initiating a 70 mg group to evaluate expanded drug exposure in ablative contexts.
Opus Genetics (NASDAQ: $IRD) announced interim three-month results from the low-dose Phase 1/2 trial of OPGx-BEST1 in BEST1-associated retinal conditions, demonstrating a clean safety profile with zero serious adverse events, dose-limiting toxicities, or intraocular inflammation among five treated subjects; alongside early microperimetry efficacy signals observed in 75% of evaluable patients, the company plans to commence pivotal dosing in 2027 following the completion of Phase 3 and commercial manufacturing scale-up.
Tenon Medical (NASDAQ: $TNON) fully settled roughly $5.16 million in senior convertible debt prior to maturity, removing future share dilution risks via discounted note conversions; while strengthening capital flexibility to propel sales expansion for its Catamaran and SImmetry+ SI joint fusion technologies, the announcement focuses on debt retirement rather than clinical updates.
Pyxis Oncology (NASDAQ: $PYXS) disclosed updated Phase 1 findings for single-agent MICVO across 2L+ recurrent or metastatic head and neck squamous cell carcinoma, demonstrating a 36% confirmed ORR alongside a 94% disease control rate, 6.2-month median progression-free survival, and 79% 12-month OS rate; featuring enhanced tolerability via dose capping without novel safety signals, the company targets an End-of-Phase 2 FDA session in 1Q 2027 ahead of starting the Phase 3 Headliner trial by mid-2027.
#BIAF #IRD #PYXS #TNON #TYRA | 34 |
| 14 |  No text... | 47 |
| 15 |  No text... | 47 |
| 16 | ⬇ continuation ⬇
Company: $AZN - AstraZeneca PLC
Drug: tozorakimab - (OBERON) (Chronic Obstructive Pulmonary Disease)
Stage: PDUFA
Catalyst: Phase 3 trial met primary endpoint, noted March 27, 2026. Phase 3 study showed statistically significant 29%-34% reductions in moderate-to-severe exacerbations across former and overall smoker populations, with benefit across eosinophil thresholds, favorable safety and U.S. Priority Review accepted ahead of an anticipated Q1 2027 PDUFA decision, noted September 8, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $FTH - Faeth Therapeutics Inc.
Drug: Serabelisib and sapanisertib (FTH-PIK-201) - (PIKTOR) (Endometrial Cancer)
Stage: Phase 2
Catalyst: Phase 1b additional data to be shared at Key Opinion Leader on October 6, 2026. Phase 2 ongoing on track to shared topline data in year end 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $SRZN - Surrozen Inc.
Drug: SZN-8141 - (DUET) (Diabetic macular edema)
Stage: Phase 1/2
Catalyst: Phase 1/2 planned by year-end 2026, with initial data expected in 2H 2027.
〰〰〰〰〰〰〰〰〰〰〰
Company: $GPCR - Structure Therapeutics Inc.
Drug: Aleniglipron (GSBR-1290) - (ACCOMPLISH-1) (Chronic weight management.)
Stage: Phase 3
Catalyst: Phase 3 study ongoing with topline data expected in 2H 2028.
〰〰〰〰〰〰〰〰〰〰〰
Company: $GPCR - Structure Therapeutics Inc.
Drug: Aleniglipron (GSBR-1290) - (ACCOMPLISH-2) (Chronic weight management.)
Stage: Phase 3
Catalyst: Phase 3 study ongoing with topline data expected in 2H 2028.
〰〰〰〰〰〰〰〰〰〰〰
#AZN #FTH #GPCR #SRZN | 47 |
| 17 | 💊 Pipeline updates
〰〰〰〰〰〰〰〰〰〰〰
Company: $NTLA - Intellia Therapeutics Inc.
Drug: Lonvoguran ziclumeran (lonvo-z, formerly NTLA-2002) - (HAELO) (Hereditary angioedema)
Stage: PDUFA priority review
Catalyst: PDUFA Priority Review date of March 10, 2027.
〰〰〰〰〰〰〰〰〰〰〰
Company: $PHVS - Pharvaris N.V.
Drug: Deucrictibant (PHVS416) - (CHAPTER-3) (Hereditary angioedema - prophylactic use)
Stage: New Drug Application Filing
Catalyst: New Drug Application submission planned for 1H 2027. Phase 3 study primary endpoint and all secondary efficacy endpoints were met with statistical significance, noted September 8, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $PYXS - Pyxis Oncology Inc.
Drug: micvotabart pelidotin (PYX-201-101) - (MICVO) (Solid tumors)
Stage: Phase 1
Catalyst: Phase 1 monotherapy data to be shared at presentation on September 9, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $DFTX - Definium Therapeutics Inc.
Drug: DT120 ODT (Lysergide (LSD)) - (Emerge) (Major Depressive Disorder)
Stage: Phase 3
Catalyst: Breakthrough Therapy Designation granted by the FDA, noted September 8, 2026. Phase 3 topline study met its primary endpoint, noted June 22, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $ROIV - Roivant Sciences Ltd.
Drug: Mosliciguat - (PHocus) (Pulmonary hypertension associated with interstitial lung disease)
Stage: Phase 2
Catalyst: Phase 2 trial met its primary endpoint, noted September 8, 2026. Phase 3 PHrontier study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease has been initiated, with enrollment underway.
〰〰〰〰〰〰〰〰〰〰〰
Company: $COYA - Coya Therapeutics Inc.
Drug: COYA 303 (COYA 301 + GLP-1RA) (Alzheimer's Disease)
Stage: Preclinical
Catalyst: Preclinical results showed complementary immunomodulatory effects of COYA 303, a combination of proprietary low-dose IL-2 (LD-IL2) and a GLP-1 Receptor Agonist (GLP-1RA), compared to either LD-IL2 or GLP-1RA as monotherapy, noted September 8, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $NVS - Novartis AG,
Drug: RNA - Atrium Therapeutics Inc. (Delpacibart Etedesiran (del-desiran) - (HARBOR))
Stage: Phase 3
Catalyst: Phase 3 study did not meet its primary endpoint, noted September 8, 2026.
〰〰〰〰〰〰〰〰〰〰〰
Company: $VOR - Vor Biopharma Inc.
Drug: Telitacicept - (UPSTREAM MG) (Generalized Myasthenia Gravis)
Stage: Phase 3
Catalyst: Phase 3 enrollment completed, noted September 8, 2026. Phase 3 24-week primary endpoint topline data due in 1H 2027. Phase 3 data presented at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting reported an 100% of patients on telitacicept for 48 weeks achieved ≥2-point Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement, with a mean reduction of -7.5 points, noted October 29, 2025.
〰〰〰〰〰〰〰〰〰〰〰
Company: $BMY - Bristol-Myers Squibb Company,
Drug: ZBIO - Zenas BioPharma Inc. (Obexelimab - (INDIGO))
Stage: PDUFA
Catalyst: PDUFA date on May 27, 2027.
〰〰〰〰〰〰〰〰〰〰〰
Company: $AZN - AstraZeneca PLC
Drug: tozorakimab - (TITANIA) (Chronic Obstructive Pulmonary Disease)
Stage: PDUFA priority review
Catalyst: Phase 3 study showed statistically significant 29%-34% reductions in moderate-to-severe exacerbations across former and overall smoker populations, with benefit across eosinophil thresholds, favorable safety and U.S. Priority Review accepted ahead of an anticipated Q1 2027 PDUFA decision, noted September 8, 2026.
〰〰〰〰〰〰〰〰〰〰〰
#AZN #BMY #COYA #DFTX #NTLA #NVS #PHVS #PYXS #ROIV #VOR | 25 |
| 18 | ⬇ continuation ⬇
Roivant Sciences (NASDAQ: $ROIV) reported positive Phase 2 PHocus findings evaluating inhaled mosliciguat for pulmonary hypertension associated with interstitial lung disease, achieving a 56.3% placebo-adjusted PVR reduction by Week 16 and adding 35.2 meters in Six-Minute Walk Distance; backed by 24-week biomarker improvements in NT-proBNP alongside functional gains, the firm plans to initiate the pivotal Phase 3 PHrontier study. Shares closed up 19% at $41.48.
GRI Bio (NASDAQ: $GRI) revealed fresh Phase 2a GRI-0621-IPF-02 translational biomarker findings in Idiopathic pulmonary fibrosis, demonstrating aligned anti-fibrotic and tissue-repair signals across RNA sequencing, extracellular matrix markers, flow cytometry, and clinical observations; with 18 key transcripts and 13 flow-cytometry metrics attaining statistical significance, the outcomes back progression of GRI-0621 toward extended clinical testing while FVC continues as an exploratory endpoint in the 35-patient trial.
#GRI #ROIV | 19 |
| 19 | 📰 Daily Biotech Stock Updates
〰〰〰〰〰〰〰〰〰〰〰〰
----------------------------------------- * PDS Biotechnology (PDSB) +36%:* Raised $22.55M in a Nant Capital-led private investment in public equity and added Patrick Soon-Shiong to its board. * Lexaria Bioscience (LEXX) -34%:* Secured about $5.9M through warrant exercises alongside new Series A and B warrants. * Bluejay Diagnostics (BJDX) +24%:* Partnered with Lovell Government Services to build federal procurement channels for Symphony. * Roivant Sciences (ROIV) +19%:* Phase 2 PHocus showed a 56.3% placebo-adjusted PVR reduction with mosliciguat in pulmonary hypertension associated with interstitial lung disease; Phase 3 PHrontier is planned. * Pharvaris (PHVS) +7%:* Phase 3 CHAPTER-3 met its primary endpoint with an 83% reduction in Hereditary Angioedema attacks; New Drug Application filing is targeted for 1H 2027. * Jaguar Health (JAGX) -31%:* Launched Neonorm Dog on Amazon, expanding its veterinary OTC product portfolio. Biotech Updates ---------------
Lexaria Bioscience (NASDAQ: $LEXX) executed warrant exercise transactions anticipated to yield roughly $5.9 million in gross capital at an adjusted $12.92 exercise rate; by distributing fresh Series A and short-term Series B warrants, the firm bolstered immediate funding for operational needs and R&D efforts through 2027, complemented by a newly secured $2.6 million Australian tax refund. Shares closed down 34% at $9.37.
PDS Biotechnology (NASDAQ: $PDSB) completed a private investment in public equity investment generating approximately $22.55 million in gross proceeds, led by Nant Capital, to support late-stage evaluations of PDS0301 across solid tumor indications; alongside appointing Dr. Patrick Soon-Shiong to its board of directors, the transaction grants NantWorks a 12-month exclusive window to negotiate licensing rights for PDS0101, emphasizing strategic financing and corporate structuring over near-term trial readouts. Shares closed up 36% at $0.30.
Bluejay Diagnostics (NASDAQ: $BJDX) entered into a strategic arrangement alongside Lovell Government Services to unlock federal procurement opportunities for its experimental Symphony system, opening distribution channels across VA, Department of Defense, and IHS facilities subject to future FDA clearances; while expanding institutional commercial pathways, the deal prioritizes long-term sales channels over active study updates or near-term top-line impact. Shares closed up 24% at $1.03.
Jaguar Health (NASDAQ: $JAGX) introduced Neonorm Dog via Amazon as a over-the-counter botanical digestive care solution, expanding its veterinary brand into canine health following prior livestock products; while unlocking an incremental retail venue, the strategic move emphasizes immediate web-based product reach rather than clinical trial readouts or regulatory milestones, with broader e-commerce availability on sites like Chewy planned. Shares closed down 31% at $0.41.
Pharvaris (NASDAQ: $PHVS) disclosed pivotal Phase 3 CHAPTER-3 outcomes for once-daily oral deucrictibant XR in Hereditary Angioedema prophylaxis, hitting its primary endpoint via an 83% attack-rate decrease against placebo across all Hereditary Angioedema variations alongside an 87% decline in Type 1/2 subjects; supported by full achievement of secondary efficacy markers and a clean safety profile devoid of therapy-linked serious adverse events, the company targets a U.S. New Drug Application filing during 1H 2027. Shares closed up 7% at $37.84.
#BJDX #JAGX #LEXX #PDSB #PHVS | 37 |
| 20 |  No text... | 47 |
