The Week Ahead In Biotech: Cara FDA Decision, Ascendis Earnings, Aileron Data Presentation And More

The Week Ahead In Biotech: Cara FDA Decision, Ascendis Earnings, Aileron Data Presentation And More

Biotech stocks swayed back and forth before ending the week lower. With earnings news dying down and an empty initial public offerings calendar, it was broader market cues, clinical readouts and regulatory actions that moved stocks during the week.

Virpax Pharmaceuticals, Inc.VRPX was among the biggest gainers of the week following a positive regulatory communication regarding its MMS019.

Sesen Bio, Inc. SESN extended its losses that were set in motion by an unexpected FDA rejection of its investigational bladder cancer drug Vicineum.

Eli Lilly and Company LLY and partner Boehringer Ingelheim received Food and Drug Administration approval for Jardiance as a treatment option for a specific type of heart failure. The regulator also granted accelerated approval for GlaxoSmithKline's GSK Jemperli for patients with previously treated, mismatch repair-deficient solid cancers. This is the second approval granted to the anti-PD-1 antibody treatment.

Among other key developments of the week was Lilly reorganizing its business with the objective of giving increased focus to its neuroscience business. Johnson & Johnson, Inc. JNJ announced the transitioning of CEO Alex Gorsky to the role of executive chairman and the elevation of insider Joaquin Duato as CEO.

Here are the key catalytic events scheduled for the unfolding week.

Related Link: Novavax Appoints New CFO Amid Inordinate Delay In COVID-19 Vaccine Authorization

Conferences

International Society for Experimental Hematology, ISEH, 2021 Virtual Scientific Meeting: Aug. 25-28

PDUFA Dates

The FDA is scheduled to rule on Axsome Therapeutics, Inc.'s AXSM dextromethorphan-bupropion (AXS-05) as a treatment option for major depressive disorder. The PDUFA date is set for Sunday, Aug. 22. The prospect of approval coming through by the deadline is bleak, as the company indicated in its Aug. 9 earnings release that the FDA has identified deficiencies in the application.

Cara Therapeutics, Inc. CARA and Vifor Pharma await an FDA nod for the new drug application for their Korsuva injection to treat moderate-to-severe pruritus in hemodialysis patients. The decision is due by Monday, Aug. 22.

Clinical Readouts

Aileron Therapeutics, Inc. ALRN will present at the ISEH meeting. final data from the completed Phase 1b trial of ALRN-6924 in patients with small-cell lung cancer and initial findings from ongoing healthy volunteer Study of ALRN-6924.

Earnings

Ascendis Pharma A/S ASND (Wednesday, after the close)

IPOs

IPO Quiet Period Expiry

  • Icosavax, Inc. ICVX
  • Rallybio Corporation RLYB
  • Nuvalent, Inc. NUVL
  • MaxCyte, Inc. MXCT
  • Omega Therapeutics, Inc. OMGA
  • Rain Therapeutics Inc. RAIN
  • RxSight, Inc. RXST
  • Immuneering Corporation IMRX
  • IN8bio, Inc. INAB
  • Tenaya Therapeutics, Inc. TNYA
  • ABVC BioPharma, Inc. ABVC

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates

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