The Week Ahead In Biotech: Endo, Eagle Pharma FDA Decisions, ObsEva Late-Stage Readouts In Focus

Biotech stocks rebounded in the holiday-shortened week ending July 2 as investors reacted to pending clinical trial readouts and the news flow surrounding COVID-19 vaccine and treatment development. 

Australian biopharma Alterity Therapeutics Ltd ATHE was among the biggest gainers of the week after the company said it received FDA guidance for the Phase 2 study for its Parkinsonian disorder drug.

Inovio Pharmaceuticals Inc INO and Pfizer Inc. PFE/ BioNTech SE – ADR BNTX were among the companies that issued updates on their coronavirus vaccine programs. 

The week also saw FDA issuing guidance on the approval of COVID-19 vaccines, with the agency suggesting a vaccine needs to demonstrate at least 50% efficacy in a placebo-controlled trial.

The following are key catalysts for the unfolding week:

Conferences

SVB Leerink Biopharma Private Company Connect: July 7-9
The Society for Pediatric Dermatology, or SPD, 45th Annual Meeting (virtual): July 10-12)

PDUFA Dates

BioSpecifics Technologies Corp. BSTC and its marketing partner Endo International PLC ENDP await the FDA's decision on the BLA for collagenase clostridium histolyticum in treating cellulite (Monday)

The FDA is also due to rule on Eagle Pharmaceuticals Inc's EGRX NDA for Ryanodex, which is being evaluated as a potential treatment option for exertional heat stroke. (Wednesday)

Related Link: Global Blood Analyst Projects More Than 60% Upside On Receding Sickle Cell Drug Concerns

Clinical Readouts

Obseva SA OBSV will release Phase 3 PRIMROSE 1, six-month primary endpoint results, and PRIMROSE 2 12-month data for Linzagolix in uterine fibroids. (Monday ahead of the market open)

Update: ObSeva reported positive results for the late-stage PRIMROSE 1 and PRIMROSE 2 studies that evaluated its linzagolix in uterine fibroids. The stock was reacting negatively, with SVB Leerink analyst Ami Fadia attributing the weakness to underwhelming PRIMOSE 1 data relative to PRIMEROSE 2 data.

Abeona Therapeutics Inc ABEO is due to present two abstracts related to its clinical program for recessive dystrophic epidermolysis bullosa, or RDEB, at the SPD annual meeting. The company will present detailed data on long-term pain relief following durable healing of wounds in RDEB patients treated with EB-101 in a Phase 1/2 study.

IPO Quiet Period Expiry

• Lantern Pharma Inc. LTRN
• Burning Rock Biotech Ltd BNR
• Generation Bio Co GBIO
• Vaxcyte Inc PCVX
• Avidity Biosciences Inc RNA
• Royalty Pharma plc RPRX

Other Events

Chembio Diagnostics Inc CEMI is scheduled to announce its current plans for COVID-19 product development and regulatory approvals and its preliminary estimates of revenue results for the quarter ended June 30, 2020. (Monday after the close)

Incidentally, FDA emergency use authorization for Chembio's SARS-CoV-2 antibody test was revoked last month.

See also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates