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Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling the Peaks
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(Stocks hitting 52-week highs on April 30)
- CareDx Inc (NASDAQ:CDNA)
- Eleven Biotherapeutics Inc (NASDAQ:EBIO)
- Sophiris Bio Inc (NASDAQ:SPHS)
- Vericel Corp (NASDAQ:VCEL)
Down In The Dumps
(Stocks hitting 52-week lows on April 30)
- Avadel Pharmaceuticals PLC (ADR) (NASDAQ:AVDL)
- Biocept Inc (NASDAQ:BIOC)
- Clovis Oncology Inc (NASDAQ:CLVS)
- Cue Biopharma Inc (NASDAQ:CUE) (on resignation of interim CFO Gary Schuman)
- Evolus Inc (NASDAQ:EOLS)
- Gemphire Therapeutics Inc (NASDAQ:GEMP)
- Mallinckrodt PLC (NYSE:MNK)
- Stellar Biotechnologies Inc (NASDAQ:SBOT)
- X T L Biopharmaceuticals Ltd (ADR) (NASDAQ:XTLB)
See Also: FDA Clears New Drug Application For Pluristem's PLX-R18; What's Next?
Stocks In Focus
Karyopharma's "STORM" Study Turns In Positive Results
Karyopharm Therapeutics Inc (NASDAQ:KPTI) announced that a Phase 2b study, dubbed "STORM" that evaluated its lead candidate selinexor in heavily pre-treated patients with multiple myeloma produced positive results. Top-line results showed that the pipeline candidate achieved 25.4 percent overall response rate and median duration of response of 4.4 months in patients with penta-refractory myeloma.
The company said it plans to submit a NDA to the FDA in the second-half of 2018.
The stock soared after hours Monday and was trading up about 25 percent at $16.35 in Tuesday's pre-market session.
Waiting Period for Novartis Proposed Buy Of AveXis Expires
AveXis Inc (NASDAQ:AVXS) said the anti-trust waiting period for its proposed acquisition by Novartis AG (ADR) (NYSE:NVS) expired at 11:59 p.m. ET on April 30. The companies entered into a merger agreement on April 17, which provided for the latter acquiring the former for $218 per share. The tender offer is expected to close on May 14.
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Novartis also received FDA nod for its Tafinlar+ Mekinist for adjuvant treatment of BRAF V600 mutant melanoma.
Inogen Rallies On Earnings
Inogen Inc (NASDAQ:INGN) shares rallied over 25 percent to $176 in after-hours trading after reporting better-than-expected Q1 results. The company also raised 2018 revenue and earnings guidance.
Neurocrine Biosciences FQ1 Capitalizes On Newly-approved Ingrezza
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) reported a narrower-than-expected loss and higher-than-expected net product sales for Q1.The sales performance came solely from Ingrezza, which was approved on April 11, 2017 for the treatment of adults with tardive dyskinesia.
Strong demand for Ingrezza led to an increase in the expense guidance, traced back to an expansion in salesforce.
Eloxx, Sangmo Gain On Completion of Common Stock Offerings
Sangamo Therapeutics Inc (NASDAQ:SGMO) added 1.27 percent to $16 and Eloxx Pharmaceuticals Inc (NASDAQ:ELOX) rose 4.32 percent to $12.80.
Both companies announced completion of common stock offerings. Sangamo had priced its 14.16 million common stock offering at $16.25 per share, while the latter priced its 5.9-million share offering at $9.75.
AzurRx Retreats On Announcement of Common Stock Offering
AzurRx BioPharma Inc (NASDAQ:AZRX) shares pulled back by 8 percent to $2.53 after the company announced an offering of its common stock. The company said it intends to use the net proceeds to meet R&D expenses associated with its clinical program of MS1819, advancing its pre-clinical program for AZX1103, and for general corporate purposes and capital expenditure.
See Also: The Week Ahead In Biotech: PDUFA Dates, Clinical Trials, Merck And Pfizer Earnings On Tap
On The Radar
The following companies report earnings on Tuesday:
- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL)
- Gilead Sciences, Inc. (NASDAQ:GILD)
- Merck & Co., Inc. (NYSE:MRK) Q1 Adj. EPS $1.05 Beats $1.00 Est., Sales $10.04B Misses $10.10B Est.
- NeoGenomics, Inc. (NASDAQ:NEO) Q1 Adj. EPS $0.04 Beats $0.03 Est., Sales $63.42B Beats $61.21B Est.
- Pfizer Inc. (NYSE:PFE) Q1 Adj. EPS $0.77 Beats $0.75 Est., Sales $12.91B Misses $13.15B Est.
Other Events
FDA's Antimicrobial Drugs Advisory Committee is scheduled to discuss SIGA Technologies, Inc. (NASDAQ:SIGA)‘s NDA for tecovitimat to treat smallpox caused by variola virus in adults and pediatric patients. The PDUFA date is set for Aug. 8.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.