The Week Ahead In Biotech (May 23-29): Eton, Lantheus FDA Decisions, Adcom Test For Provention, Chiasma Data Presentation

Biotech stocks advanced in the week ended May 21, as risk aversion forced traders to buy into defensives. As earnings news flow tapered, stocks took cues from clinical readouts.

The American Society of Clinical Oncology, which is set to hold its meeting June 4-8, published abstracts submitted by presenters at the conference. These abstracts triggered some stock-specific reactions.

The week witnessed a few top-level executive departures. Cancer biotech Idera Pharmaceuticals, Inc. IDRA lost its chief medical officer. Gene therapy company Passage Bio, Inc. PASG announced the departure of its CMO, while it said its chief financial officer will also leave by this month's end.

Voyager Therapeutics, Inc.'s (VYGR) chief executive officer and CMO called it quits, with the company announcing renewed focus on TRACERT gene therapy technology platform and next-generation targeted AAV capsids.

Moderna, Inc. MRNA said its COVID-19 vaccine was approved for emergency use in Japan, while Pfizer, Inc. PFE-BioNTech SE BNTX received incremental orders from the European Union for the supply of their COVID-19 vaccines.

Here are the key catalytic events for the unfolding week:

Conferences

The UBS Global Healthcare Virtual Conference: May 24-26

The SynBioBeta Synthetic Biology Biopharma Conference: May 26

The Benchmark Company Healthcare House Call Conference: May 26

American Association of Clinical Endocrinology, AACE, 2021 Annual Meeting: May 26-29

PDUFA Dates

Eton Pharmaceuticals, Inc. ETON has two FDA decisions coming up in the unfolding week. The FDA is scheduled to rule on the company's new drug application for dehydrated alcohol injection for the treatment of methanol poisoning, by the PDUFA date of Thursday, May 27. The regulatory agency will also announce its decision on the company's zonisamide oral suspension in epilepsy by the PDUFA date of Saturday, May 29.

Lantheus Holdings, Inc.'s LNTH NDA for PyL, an investigational fluorinated PSMA-targeted PET imaging agent, has a PDUFA action date of Friday, May 28.

Related Link: Why Biogen's June 7 Aducanumab PDUFA Date Is A High-Risk, High-Reward Catalyst

Adcom Meeting

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Thursday, May 27 to discuss Provention Bio, Inc.'s PRVB biologics license application for teplizumab intravenous infusion, for the delay or prevention of clinical type 1 diabetes mellitus in at-risk individuals.

In late April, the company said the FDA had communicated regarding deficiencies the agency identified in the regulatory application. The pharmacokinetic profiles of the company's candidate and Eli Lilly and Company's LLY original drug substance used in the bridging study are not comparable, according to the regulatory agency.

Clinical Readouts/Presentations

Chiasma, Inc. CHMA is scheduled to virtually present at the AACE meeting encore new data from the MPOWERED Phase 3 study of Mycapssa in adults with acromegaly. (Wednesday, May 26)

Earnings

Burning Rock Biotech Limited BNR (Tuesday, before the market open)
Trinity Biotech plc TRIB (Tuesday, before the market open)
Medtronic plc MDT (Wednesday, before the market open)
Ascendis Pharma A/S ASND Wednesday, after the close)

IPO Quiet Period Expiry

Vaccitech plc VACC
Werewolf Therapeutics, Inc. HOWL

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

Posted In: BiotechNewsPenny StocksSmall CapFDA

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