Stocktwits Pharma Pulse: Big Pharma Earnings, Cancer Updates And 2 FDA Deadlines - The Week's Biotech Watchlist

(MENAFN- AsiaNet News)

• Oruka reports Phase 2b psoriasis results on Monday, providing another test of ORKA-001's ability to clear skin with less frequent dosing.
• Incyte discusses its ESMO cancer findings on Monday, while Iovance presents Lifileucel data in soft-tissue cancers.
• Beam reviews initial Beam-301 findings on Tuesday, while Benitec presents BB-301 data at the European gene-therapy congress.

Biotech stocks enter the week following strong gains, with investor attention turning to Eli Lilly and Merck's earnings, Oruka Therapeutics' psoriasis readout and three approaching FDA deadlines.

Healthcare and biotech stocks outperformed the broader market in the week ended Oct. 23. The Health Care Select Sector SPDR Fund (XLV) rose 1.5%, while the iShares Biotechnology ETF (IBB) gained 2.9% and the SPDR S & P Biotech ETF (XBI) climbed 3.6%. By comparison, the SPDR S & P 500 ETF Trust (SPY) fell 0.4%, and the Invesco QQQ Trust (QQQ) declined 0.8%.

 

Date	Ticker/Event	Development
Oct.26	ORKA	Everlast-B Phase 2b Week 16 psoriasis data
Oct.26	INCY	ESMO investor webcast, 2:30 p.m. - 4 p.m. ET
Oct.26-Oct.27	ESMO / IOVA	Final congress sessions; Lifileucel sarcoma presentation on Monday
Oct.27	NVS / BEAM	Novartis Q3 results; Beam-301 data webcast at 8 a.m. ET
Oct.28	BIIB / GSK	Q3 results
Oct.29	LLY / MRK / BMY / GILD	Q3 results; Gilead reports after the close
Oct.30	ABBV / AZN / REGN / SNY	Q3 results
Oct.30	INO	FDA target date for INO-3107 in adult recurrent respiratory papillomatosis
Nov.1	AGIO	FDA target date for Mitapivat in sickle cell disease

Oruka's Psoriasis Data And Cancer Updates Open The Week

Oruka Therapeutics (ORKA) opens Monday with 16-week results from Everlast-B, its Phase 2b trial of Orka-001 in moderate-to-severe plaque psoriasis. The long-acting IL-23 antibody is being developed for less frequent dosing. In the earlier Phase 2a Everlast-A trial, 63.5% of treated patients achieved completely clear skin at Week 16, rising to 71.4% at Week 28 after doses only at Weeks 0 and 4.

Incyte (INCY) follows with an investor webcast on its ESMO cancer findings and pipeline. Highlights include INCB161734, which targets the KRAS G12D cancer mutation in colorectal and pancreatic cancers, and dual-target antibody INCA33890. The findings come from early-stage studies, with separate Phase 3 trials underway.

ESMO Congress continues through Tuesday in Madrid. Iovance Biotherapeutics (IOVA) presents Monday on Lifileucel, which uses patients' own immune cells to fight cancer, in two previously treated soft-tissue sarcomas. The data come from a Memorial Sloan Kettering-led pilot trial.

Summit Therapeutics (SMMT) enters the week after reporting positive Harmoni-GI1 results on Sunday. In the China-based Phase 3 trial, Ivonescimab plus chemotherapy reduced the risk of death by 25% compared with Durvalumab plus chemotherapy in advanced biliary tract cancer. Median overall survival was 14.9 months versus 12.1 months at the interim analysis.

Lilly, Merck And AbbVie Lead Earnings Lineup

Novartis (NVS) reports Tuesday, followed by Biogen (BIIB) and GSK on Wednesday. Thursday's lineup includes Eli Lilly (LLY), Merck (MRK), Bristol Myers Squibb (BMY) and Gilead Sciences (GILD), which reports after the market closes. AbbVie (ABBV), AstraZeneca (AZN), Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) follow on Friday.

Lilly's results will test momentum in its diabetes and obesity business after Mounjaro and Zepbound helped drive second-quarter growth and the company raised its full-year revenue outlook. GSK reports after the recent FDA approval of Hibsago, or Bepirovirsen, its Ionis-partnered chronic hepatitis B treatment. 

Early Gene-Therapy Results Enter The Spotlight

Beam Therapeutics (BEAM) reviews initial Phase 1/2 Beam-301 data in glycogen storage disease type Ia on Tuesday. Additionally, Benitec Biopharma (BNTC) will present BB-301 findings at the Oct.27-Oct.30 European Society of Gene and Cell Therapy congress.

Inovio And Agios Await FDA Action

Inovio (INO) has a Friday target date for INO-3107, a DNA immunotherapy for adults with recurrent respiratory papillomatosis, which causes recurring airway growths. The company is seeking accelerated approval on a standard FDA review timetable.

The FDA previously questioned the application's eligibility for accelerated approval. In August, Inovio's said its late-cycle meeting and pre-license inspections were complete, with cash expected to last into late first-quarter 2027.

Meanwhile, Agios (AGIO) closes the weekly calendar with a Sunday target date for Mitapivat in sickle cell disease. The application received Priority Review and is seeking accelerated approval based on Phase 2 and Phase 3 Rise Up results. Mitapivat is already approved in the U.S. for pyruvate kinase deficiency and thalassemia.

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