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 11)
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Affimed N.V. (NASDAQ: AFMD)
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AngioDynamics, Inc. (NASDAQ: ANGO)
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Apyx Medical Corporation (NASDAQ: APYX)
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AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO)
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Axonics Modulation Technologies, Inc. (NASDAQ: AXNX)
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BioAtla, Inc. (NASDAQ: BCAB)
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BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
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Bolt Biotherapeutics, Inc. (NASDAQ: BOLT)
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Entera Bio Ltd. (NASDAQ: ENTX) ( announced positive Phase 2 biomarker data for osteoarthritis drug)
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Harvard Bioscience, Inc. (NASDAQ: HBIO)
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IDEAYA Biosciences, Inc. (NASDAQ: IDYA)
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Inari Medical, Inc. (NASDAQ: NARI)
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Jounce Therapeutics, Inc. (NASDAQ: JNCE)
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Longeveron Inc. (NASDAQ: LGVN) (announced FDA granting expanded access approval for its investigational cell therapy Lomecel-B to a pediatric patient with hypoplastic left heart syndrome)
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Magenta Therapeutics, Inc. (NASDAQ: MGTA)
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Nuvation Bio Inc. (NASDAQ: NUVB)(announced orphan drug designation for NUV-422 in treating malignant gliomas)
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Renalytix AI plc (NASDAQ: RNLX)
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Sol-Gel Technologies Ltd. (NASDAQ: SLGL)
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Surmodics, Inc. (NASDAQ: SRDX)
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Verrica Pharmaceuticals Inc. (NASDAQ: VRCA)
Down In The Dumps
Stocks In Focus
Novavax Confirms Efficacy Data Following Final Analysis of U.K. Phase 3 Data
Novavax, Inc. (NASDAQ: NVAX) announced final data from the U.K. leg of the Phase 3 study of its coronavirus vaccine candidate NVX-CoV2373, showing efficacy of 96.4% against the original COVID-19 strain. Final data also showed that efficacy fell to 86.3% against the B.1.1.7 variant circulating in the U.K.
Overall efficacy was 89.7%, slightly higher than the 89.3% reported based on preliminary analysis in late January.
The company also announced a complete analysis of data from the Phase 2b study in South Africa, showing a 55.4% efficacy among HIV-negative trial participant, where the vast majority of the strains were of the B1.351 variants.
The stock climbed 23.11% to $231 in after-hours trading.
ContraFect Gets $86.8M In BARDA Funding For Phase 3 Study of Investigational Asset to Treat Bacterial Infection In Bloodstream
ContraFect Corporation (NASDAQ: CFRX) said it has been awarded a cost-share contract for supporting its ongoing pivotal Phase 3 DISRUPT superiority study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis.
The contract provides for ContraFect receiving $9.8 million in initial funding and up to an additional $77 million. if supported by Phase 3 data, BARDA may provide the company with additional funding upon achievement of key milestones to continue the advancement of exebacase through FDA product approval and completion of post-approval commitments.
The company expects results from the Phase 3 study interim futility analysis in the second half of 2021.
The stock jumped 37.17% to $8.17 in after-hours trading.
CareDx Announces Appointment of New CFO
CareDx, Inc (NASDAQ: CDNA) announced the appointment of Agilent Technologies, Inc. (NYSE: A) executive Ankur Dhingra as its new CFO, effective March 25. As CFO, Ankur will lead CareDx's global finance organization including treasury, tax, and other corporate functions, and report directly to President and CEO Reg Seeto.
Takeda Files Regulatory Application For Approval of Drug to Prevent Hereditary Angioedema In Japan
Takeda Pharmaceutical Company Limited (NYSE: TAK) said it has submitted a new drug application to Japan's Ministry of Health, Labour and Welfare for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema.
Altimmune Expands Intranasal COVID-19 Vaccoine Manufacturing Collaboration With Lonza
Altimmune, Inc. (NASDAQ: ALT) said it has expanded its previously-announced AdCOVID manufacturing collaboration with Swiss CDMO Lonza. Under the expanded agreement, Lonza will commission a dedicated manufacturing suite for clinical and commercial production of AdCOVID, Altimmune's single-dose intranasal vaccine candidate for COVID-19, at its facility near Houston, Texas.
Altimmune shares were rallying 19.67% to $20.20 in premarket trading Friday.
Sanofi-Translate Bio Start Phase 1/2 Study of COVID-19 Vaccine Candidate
Sanofi (NASDAQ: SNY) and Translate Bio, Inc. (NASDAQ: TBIO) announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2.
Translate Bio said it will receive a $25 million payment based on achievement of this milestone. The companies expect interim results from this trial in the third quarter of 2021.
Aveo to Study Fotivda In Combination With Opdivo For Kidney Cancer
Aveo announced a clinical trial collaboration with Bristol-Myers Squibb Company (NYSE: BMY) to evaluate its recently-approved Fotivda with the latter's Opdivo in a pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma following prior immunotherapy exposure.
Bristol-Myers Squibb will provide Opdivo clinical drug supply for the study and AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution.
Aveo shares were advancing 10.78% to $13.15 in premarket trading Friday, while Bristol-Myers Squibb was edging 0.33% to $60.55.
Earnings
Champions Oncology, Inc. (NASDAQ: CSBR) said its third-quarter revenues increased 10% year-over-year to $10.8 million. The earnings per share increased from 3 cents to 5 cents, while analysts had estimated a profit of 1 cent per share.
The stock rose 8.18% to $11.90 in after-hours trading.
Chembio Diagnostics, Inc.'s (NASDAQ: CEMI) fourth-quarter revenues climbed 62% year-over-year to $10.2 million. The net loss per share, however, widened from 23 cents to 35 cents, while analysts had forecast a narrower loss of 28 cents per share.
The stock slumped 10.12% to $4.44 in after-hours trading.
View more earnings on IBB
Histogen Inc. (NASDAQ: HSTO) said its fourth-quarter revenues fell from $1.6 million in 2019 to $0.5 million, with the decline primarily due to a decrease in fulfillment of supply orders of CCM to AbbVie Inc.'s (NYSE: ABBV) Allergan. The net loss per share narrowed from 70 cents to 26 cents. Analysts, on average, had estimated a loss of 35 cents per share.
In after-hours trading, the stock was down 7.75% to $1.31.
Capricor Therapeutics, Inc. (NASDAQ: CAPR) reported a fourth-quarter loss of 21 cents per share, narrower than the year-ago loss of 34 cents per share but wider than the consensus estimate for a loss of 20 cents per share.
The stock fell 7.94% to $5.10 in after-hours trading.
Geron Corporation's (NASDAQ: GERN) fiscal-year 2020 fourth-quarter loss more than halved to 7 cents per share. The loss, however, was wider than the consensus estimate that called for a loss of 6 cents per share.
In after-hours trading, the stock lost 5.29% to $1.79.
Evoke Pharma, Inc.'s (NASDAQ: EVOK) fourth-quarter net sales came in at $23,000 in 2020, as the company began marketing its gastroparesis drug Gimoti nasal spray, which was approved in late June 2020. The net loss per share widened from 6 cents to 9 cents, while analyst estimated a wider loss of 13 cents per share.
The stock plunged 29.03% to $2.20 in after-hours trading.
Offerings
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) said it intends to offer shares of its common stock for sale in an underwritten public offering. All of the shares in the proposed offering are to be sold by Cyclacel.
The stock slid 5.97% to $7.40 in after-hours trading.
Marker Therapeutics, Inc. (NASDAQ: MRKR) announced that it has commenced an underwritten public offering of shares of its common stock.
The stock was plunging 24.90% to $1.90 in premarket trading Friday.
On The Radar Earnings
Iterum Therapeutics plc (NASDAQ: ITRM)
PLx Pharma Inc. (NASDAQ: PLXP)
IPOs
Prometheus Biosciences, Inc. priced its upsized initial public offering of 10 million shares of its common stock at $19.00 per share, above the estimated price range of $16-$18. All of the shares are being offered by the company. The shares will begin trading on the Nasdaq under the ticker symbol "RXDX."
The gross proceeds from the offering, are expected to be $190 million.
Prometheus is a precision medicine company developing therapeutics and companion diagnostic products for inflammatory bowel disease.
Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing medicines for neurological diseases, priced its IPO of 5 million shares at $16.00 per share, for generating gross proceeds of $80 million.
The shares are expected to begin trading on the Nasdaq under the symbol "LBPH."
Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates
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