Week Ahead In Biotech (March 14-20): Update On Fibrogen-AstraZeneca's Anemia Drug, Earnings and Presentations

Biotech stocks snapped back from their weekly losses and ended higher for the week ended March 12, with the broader market recovery partly aiding the reversal.

Entera Bio Ltd. ENTX was the biggest gainer of the week after it disclosed Phase 2 biomarker data that showed positive efficacy for EB613, its investigational drug being evaluated in postmenopausal women with osteoporosis.

The week also witnessed a slew of updates from companies developing COVID-19 treatments and vaccines.

AVEO Pharmaceuticals, Inc. (AVEO) received the regulatory nod for its new drug application for Tivozanib, for difficult-to-treat kidney cancer that has spread from where it was originally formed. This culminates an eight-year-long wait from the initial filing date.

IPO news flow returned, with Prometheus Biosciences, Inc. Common Stock RXDX, a biopharma focusing on therapies for inflammatory bowel disease, and Longboard Pharmaceuticals, Inc. Common Stock LBPH, a neurological diseases company, debuting on Wall Street.

The two companies together raised a combined $270 million in gross proceeds from the initial public offerings.

Here are the key catalysts for the unfolding week:

Conferences

The 15th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders: March 9-14
33rd Annual Virtual ROTH Conference: March 15-17
Muscular Dystrophy Association, or MDS, Virtual Clinical & Scientific Conference: March 15-18
Morgan Stanley Virtual Innovation in Pharma Week: March 15-19
Morgan Stanley Healthcare Corporate Access Days: March 16
Oppenheimer 31st Annual Healthcare Conference (Virtual): March 16-18
The Society of Gynecologic Oncology, or SGO, 2021 Annual Meeting: March 19-25
The Endocrine Society's ENDO 2021: March 20-23

PDUFA Dates

FibroGen Inc FGEN and AstraZeneca plc's AZN roxadustat PDUFA date of March 20 (Saturday) is likely to be extended, as the FDA has decided to hold an advisory committee meeting before deciding on the new drug application. FibroGen, the sponsor of the application, is seeking approval for the drug to treat anemia in chronic kidney disease patients.

Clinical Trial Readouts/Presentations

MDA Conference Presentations

Sarepta Therapeutics, Inc. SRPT: Phase 1 data for SRP-9001 in Duchenne muscular dystrophy, and new long-term functional data from a Phase 1/2 study of gene therapy candidate SRP-9003 that is being developed for limb-girdle muscular dystrophy type 2E

Solid Biosciences Inc. SLDB: one-year efficacy and safety data from a Phase 1/2 ascending dose study of single intravenous infusion of SGT-001 microdystrophin gene therapy for Duchenne muscular dystrophy (Thursday, 4 p.m.)

SGO Meeting Presentations

Aravive, Inc. ARAV: updated data from the Phase 1b trial evaluating AVB-500 in platinum resistant ovarian cancer (Friday, 3:35 p.m.); additionally, new information is to be presented on the Phase 1/2 investigator-sponsored trial of AVB-500 in combination with durvalumab in patients with platinum resistant, recurrent epithelial ovarian cancer

Leap Therapeutics, Inc. LPTX: Additional data from the Phase 2 study of DKN-01 and Paclitaxel chemotherapy medication in endometrial cancer

ENDO Meeting Presentations

BridgeBio Pharma, Inc. BBIO: Early results from a Phase 2b study of encaleret on mineral physiology in autosomal dominant hypocalcemia type 1, a rare form of hypoparathyroidism

Rhythm Pharmaceuticals, Inc. RYTM: data from the Phase 2 study of setmelanotide in obesity patients and Phase 3 study data for the same investigational therapy in treating obesity due to Bardet-Biedl syndrome or Alstrom syndrome

Spruce Biosciences, Inc. SPRB: data from the Phase 1 and 2 program of tildacerfont for the treatment of classic congenital adrenal hyperplasia

Strongbridge Biopharma plc. SBBP: Interim safety and efficacy results, including new data analyses, from the Phase 3 LOGICS study that is evaluating COR-003 in endogenous Cushing's syndrome

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

Standalone Releases

Eli Lilly and Company LLY will present an update on the TRAILBLAZER clinical trial program as well as an update on the Phase 2 TRAILBLAZER-ALZ 2 trial at a webcast on Monday at 10:30 a.m. The Phase 2 trial is evaluating Lilly's investigational drug donanemab for Alzheimer's disease.

Secondary analyses of data from the Phase 2 study presented over the weekend at the 15th Conference on Alzheimer's & Parkinson Diseases showed donanemab consistently slowed cognitive and functional decline. Prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer's disease.

In Alzheimer's patients, tau protein molecules found in neurons of the brain bind with each other to form tangles inside the neurons, disrupting synaptic communication between neurons.

Rubius Therapeutics, Inc. RUBY is scheduled to issue a pre-market press release and conduct a webcast on Monday to discuss the initial clinical data findings from the ongoing Phase 1/2 trial of RTX-240 in patients with advanced solid tumors.

Earnings

Monday

Agenus Inc. AGEN (before the market open)
Enzo Biochem, Inc. ENZ (before the market open)
Corbus Pharmaceuticals Holdings, Inc. CRBP (before the market open)
AcelRx Pharmaceuticals, Inc. ACRX (after the close)
Amphastar Pharmaceuticals, Inc. AMPH (after the close)
Catalyst Pharmaceuticals, Inc. CPRX (after the close)

Tuesday

Calithera Biosciences, Inc. CALA (after the close)
Cue Biopharma, Inc. CUE (after the close)
Curis, Inc. CRIS (after the close)
Kindred Biosciences, Inc. KIN (after the close)
Exagen Inc. XGN (after the close)
OncoCyte Corporation OCX (after the close)
Eton Pharmaceuticals, Inc. ETON (after the close)
Organogenesis Holdings Inc. ORGO (after the close)
Infinity Pharmaceuticals, Inc. INFI (after the close)
Ra Medical Systems, Inc. RMED (after the close)

Wednesday

ThermoGenesis Holdings, Inc. THMO (after the close)

Thursday

Legend Biotech Corporation LEGN (before the market open)
PDS Biotechnology Corporation PDSB (before the market open)
Metacrine, Inc. MTCR (before the market open)
Entera Bio Ltd. ENTX (before the market open)
UroGen Pharma Ltd. URGN (before the market open)
Galmed Pharmaceuticals Ltd. GLMD (before the market open)
Acutus Medical, Inc. AFIB (after the close)
Alpine Immune Sciences, Inc. ALPN (after the close)
Viveve Medical, Inc. VIVE (after the close)
Salarius Pharmaceuticals, Inc. SLRX (after the close)

IPOs

Bethesda, Maryland-based Gain Therapeutics, Inc. is proposing to offer 3.64 million shares of its common stock in an initial public offering, with the issue expected to be priced between $10 and $12.

The clinical-stage biopharma that is focused on developing therapeutics for lysosomal storage disorders has applied for listing its shares on the Nasdaq under the ticker symbol "GANX."

IPO Quiet Period Expiry

Virpax Pharmaceuticals, Inc. VRPX

Related Link: Why 2 Acadia Pharma Analysts Are Bracing For FDA Rejection Of Nuplazid In Dementia

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