The Daily Biotech Pulse: Regulatory Setback For Acadia, Lilly Forges Diabetes Antibody Treatment Collaboration, Aytu's Positive COVID-19 Data - iShares Biotechnology ETF (NASDAQ:IBB)

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs March 8)

Axonics Modulation Technologies, Inc. AXNX
Bausch Health Companies Inc. BHC
IDEAYA Biosciences, Inc. IDYA
Marinus Pharmaceuticals, Inc. MRNS
Second Sight Medical Products, Inc. EYES (follow-on buying following FDA nod for its Argus 2 retinal prosthesis system)
Surmodics, Inc. SRDX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 8)

Decibel Therapeutics, Inc. DBTX
Foghorn Therapeutics Inc. FHTX
Freeline Therapeutics Holdings plc FRLN
Galapagos NV GLPG
Immunocore Holdings plc IMCR
Lucira Health, Inc. LHDX
Opthea Limited OPT
Reviva Pharmaceuticals Holdings, Inc. RVPH
Talis Biomedical Corporation TLIS (announced withdrawal of application for emergency use authorization for One COVID-19 test in the CLIA moderate setting)

Stocks In Focus

FDA Finds Deficiencies In Acadia's Regulatory Application For Dementia Drug

As part of its ongoing review of ACADIA Pharmaceuticals Inc.'s ACAD supplemental new drug application for pimavanserin, the FDA said in a March 3 letter it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.

Pimavanserin is being evaluated for the treatment of hallucinations and delusions associated with dementia-related psychosis.

The notification does not reflect a final decision on the information under review, the FDA said. The agency has assigned a PDUFA action date of April 3 for completing the review.

Acadia said it plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them.

The stock was down 44.67% premarket at $25.33.

Lilly To Collaborate With Biolojic To Develop Diabetes Antibody Therapy

Eli Lilly and Company LLY announced a research collaboration and license agreement with Biolojic that will leverage the latter's AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.

Under the terms of the agreement, Lilly will pay research fees associated with the collaboration. Biolojic is eligible to receive up to a total of $121 million, consisting of potential development and commercialization milestones and a promissory note that may be convertible into Biolojic equity at a future date.

Biolojic is also eligible to receive tiered royalties in the low- to mid-single digits on product sales should Lilly successfully commercialize a therapy from the collaboration.

Aytu Reports Positive Results For Pilot Study Of Ultraviolet Ray Treatment In COVID-19 Patients

Aytu BioScience, Inc. AYTU announced positive results from a pilot study that evaluated endotracheal application of ultraviolet A light in critically ill coronavirus-2 patients with severe acute respiratory syndrome. The treatment was associated with a significant reduction of SARS-CoV-2 viral load and improvement in WHO clinical severity scores. Additionally, the endotracheal UVA light treatment did not result in any serious adverse device effects and was well-tolerated.

The stock was up 11.01% premarket at $8.57.

Novartis Partner Reports Positive Results For Phase 1 Study of COVID-19 Antiviral Treatment

Novartis AG NVS and Molecular Partners announced positive results for the Phase 1 study of ensovibep, a tri-specific COVID-19 antiviral treatment, in healthy volunteers.

Preliminary results showed extended exposure of the candidate in serum, with a half-life of two to three weeks, in line with the results from preclinical experiments. These data confirm the systemic administration of a multi-specific DARPin antiviral therapy to be safe and well-tolerated, and support advanced plans for additional clinical work in positively diagnosed patients.

Roche's Companion Diagnostic Test For Lung Cancer Approved By FDA

Roche Holding AG RHHBY announced FDA approval of the ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer Inc.'s PFE drug Lorbrena.

It is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Lorbrena, the company said.

Xenon To Collaborate With Icahn School of Medicine On Midstage Study Of Depression Drug

Xenon Pharmaceuticals Inc. XENE announced a collaboration with the Icahn School of Medicine at Mount Sinai for an investigator-sponsored Phase 2 proof-of-concept clinical trial of XEN1101 for the treatment of major depressive disorder and anhedonia, which is an inability to feel pleasure. Xenon will supply the study drug.

The study is expected to commence in the second quarter of 2021.

Titan Medical Rallies On Corporate Update

In conjunction with a presentation at H.C. Wainwright conference, Titan Medical Inc. TMDI issued a corporate update, highlighting a market opportunity that it said is running at an annual rate of $18 billion. The company said it expects to generate $21 million in additional license revenue in 2021.

The stock was jumping 5.17% to $1.83 in premarket trading Tuesday.

NanoViricides Reports Positive Preclinical Results For COVID-19 Drug Candidates

NanoViricides, Inc. NNVC reported on the strong effectiveness of its two COVID-19 clinical drug candidates in an animal model of coronavirus infection. The company said it is preparing a pre-IND application encompassing its two clinical drug candidates for the treatment of COVID-19 infected patients.

The stock was rallying 8.25% to $5.38 in premarket trading Tuesday.

Takeda To Acquire Immunotherapy Company Maverick Therapeutics

Takeda Pharmaceutical Company Limited TAK announced the exercising of its option to acquire Maverick Therapeutics, a private biotech engaged in the development of immunotherapies. Under the agreement, Takeda will obtain Maverick's T-cell engager COBRA platform and a broad development portfolio.

The portfolio includes Maverick's lead development candidate TAK-186, which is in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280, which is anticipated to enter the clinic in the second half of Takeda's fiscal 2021 for the treatment of patients with B7H3-expressing solid tumors.

Earnings

Skin cancer diagnostics company Castle Biosciences, Inc. CSTL reported a decline in its fourth-quarter revenue from $17.6 million in 2019 to $17.3 million in 2020. The company reversed from a profit of 11 cents per share to a loss of 23 cents per share.

Separately, the company said its DecisionDx-Melanoma prognostic gene expression profile test for cutaneous melanoma now utilizes an integrated test result that is designed to provide a more precise risk prediction in patients with stage I, II or III melanoma.

The company said it plans to launch an app later in 2021 for dermatology clinicians, featuring an interactive algorithm using the 31-GEP test score and traditional clinicopathologic factors to predict risk.

In after-hours trading, the stock fell 6.1% to $62.05.

Cerecor Inc. CERC reported a decline in revenue from $6.75 million in fiscal year 2019 to $6.7 million in 2021. The net loss per share widened from $1.41 to $4.32, dragged by higher R&D expenses and one-time charges.

The stock moved down 5.23% to $2.90 in after-hours trading.

Offerings

Hoth Therapeutics, Inc. HOTH said it has entered a definitive agreement with certain institutional and accredited investors for the sale of an aggregate of 7.595 million shares of its common stock, and warrants to purchase up to an aggregate of 7.595 million shares of common stock, at a purchase price of $1.975 per share and accompanying warrant in a private placement priced at-the-market.

The gross proceeds to the company from the private placement are expected to be approximately $15 million. The private placement is expected to close on or about March 10, subject to the satisfaction of customary closing conditions.

The stock was down 5.7% premarket at $1.82.

On The Radar

Earnings

Orgenesis Inc. ORGS (before the market open)
Xeris Pharmaceuticals, Inc. XERS (before the market open)
Trevena, Inc. TRVN (before the market open)
InspireMD, Inc. NSPR (before the market open)
Marinus Pharmaceuticals, Inc. MRNS (before the market open)
DarioHealth Corp. DRIO (before the market open)
Gamida Cell Ltd. GMDA (before the market open)
Evelo Biosciences, Inc. (EVLO) (before the market open)
ANI Pharmaceuticals, Inc. ANIP (before the market open)
Aquestive Therapeutics, Inc. AQST (after the close)
Brickell Biotech, Inc. BBI (after the close)
Cytosorbents Corporation CTSO (after the close)
Cumberland Pharmaceuticals Inc. CPIX (after the close)
MiMedx Group, Inc. MDXG (after the close)
Inari Medical, Inc. NARI (after the close)
Lyra Therapeutics, Inc. LYRA (after the close)
Lumos Pharma, Inc. LUMO (before the market open)
Outset Medical, Inc. OM (before the market open)

Other Events

CorMedix Inc. CRMD is scheduled to host a conference call relating to a regulatory update for DefenCath at 8:30 a.m. Defencath is to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related blood stream infections. The company had a PDUFA date of Feb. 28 for the NDA for defencath, which is being evaluated for preventing catheter-related infections in hemodialysis patients.

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