The Week Ahead In Biotech: FDA Decisions In The Cards For Merck, Epizyme, Evoke And Ultragenyx

Biotech stocks came under pressure along with the broader market in the week ended June 12, as a worsening pandemic situation and its impact on the economy led to an across-the-board sell-off in the global markets.

The week kickstarted with the rumor of a big-ticket acquisition. AstraZeneca plc AZN reportedly approached Gilead Sciences, Inc. GILD with a bid, although experts and analysts shrugged off the possibility of a deal materializing.

The FDA promptly approved Viela Bio Inc's VIE drug for treating neuromyelitis optica spectrum disorder.

More importantly, five biopharma companies debuted on Wall Street, raising a combined $983.25 million. The week also witnessed virtual presentations at key conferences such as the European Hematology Association Congress.

Here are the key catalysts for the unfolding week.

Conferences

• The Endocrine Society's ENDO Online 2020: June 8-22
• 25th Edition of the European Hematology Association, or EHA, Annual Congress held in virtual format: June 11-21
• American Academy of Dermatology, or AAD, Virtual Meeting Experience: June 12-14
• The American Diabetes Association, or ADA, 80th Scientific Sessions – Virtual: June 12-16
• The World Federation of Hemophilia, or WFH, Virtual Summit: June 14-19

PDUFA Dates

The FDA is scheduled to give its verdict on Merck & Co., Inc.'s MRK Keytruda as a monotherapy option for unresectable or metastatic solid tumors, with tissue tumor mutational burden-high. (Tuesday)

Ultragenyx Pharmaceutical Inc RARE and its Japanese partner Kyowa Kirin have a tryst with the FDA, as the agency is set to rule on hypophosphatemia treatment candidate burosumab. (Thursday)

The regulatory agency will also decide on Epizyme Inc's EPZM regulatory application for label expansion for tazemetostat, this time for follicular lymphoma. (Thursday)

Nabriva Therapeutics PLC – ADR NBRV is knocking at the FDA altar for the second time for its investigational antibiotic contepo for treating complicated urinary tract infection. Late May, the company hinted at the decision being delayed due to the FDA requiring to inspect facilities of third-party manufacturers in Europe (Friday)

Evoke Pharma Inc EVOK has a PDUFA date for its Gimoti to treat women with acute and recurrent diabetic gastroparesis. (Friday)

See Also: Moderna On Track To Start Phase 3 Coronavirus Vaccine Trial In July

Adcom Meetings

FDA's Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will consider through teleconferencing the SP 2577 presentation by Salarius Pharmaceuticals Inc SLRX and marizomib, presentation by Celgene, a subsidiary of Bristol-Myers Squibb Co BMY. SP 2577 is being evaluated for the treatment of relapsed/refractory patients with Ewing sarcoma and marizomib for multiple myeloma.

The FDA said the subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate.

Clinical Readouts/Presentations

ProQR Therapeutics N.V. PRQR will make a virtual presentation of data from the Phase 1/2 trial of intravitreal sepofarsen, an antisense oligonucleotide, in Leber congenital amaurosis 10 due to p.Cys998X mutation in the CEP290 gene. The data is to be shared via a video presentation through the Association for Research in Vision and Ophthalmology. (available online from Monday)

Sanofi SA SNY is scheduled to host a virtual scientific session to present data from the Phase 3 COMET trial of investigational enzyme replacement therapy avalglucosidase alfa in patients with late-onset Pompe disease. (Tuesday)

Catalyst Biosciences Inc CBIO is due to present at the WFH virtual summit Phase 2a data for factor IX levels of a daily subcutaneous prophylaxis treatment regimen of dalcinonacog alfa in hemophilia B.

Earnings

• Centogene NV CNTG (Monday, before the market open)
• BioNano Genomics Inc BNGO (Thursday, after the close)
• Urovant Sciences Ltd UROV (Thursday, after the close)

IPOs

Royalty Pharma, which buys royalties for late-stage and commercial drugs, has filed to offer 70 million shares in an initial public offering at an estimated price range of $25-$28. The company has applied for listing its shares on the Nasdaq under the ticker symbol RPRX.

IPO Quiet Period Expiry

Inari Medical Inc NARI