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Friday, November 8, 2019

CNS Pharmaceuticals prices initial public offering

CNS Pharmaceuticals (CNSP) has priced its initial public offering of 2.125M shares of common stock at $4.00 per share, gross proceeds expected to be $8.5M.
Underwriters over-allotment is an additional 318,750 shares.
The common stock is expected to begin trading today on the NASDAQ Capital Market.
The offering is expected to close on November 13.
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TELA Bio announces pricing initial public offering

TELA Bio (TELA) has priced its initial public offering of 4M shares of common stock at $13/share, for gross proceeds of $52M.
Underwriters over-allotment is an additional 600K shares of common stock.
The shares are expected to begin trading today on The Nasdaq Global Market.
The offering is expected to close on November 13.
Previously: TELA Bio sets IPO terms (Oct. 29)
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FDA pulls Sublocade Orphan Drug status, Braeburn’s Brixadi to get nod in 2020

The FDA has granted Braeburn Pharmaceuticals’ (BBRX) Citizen Petition seeking a revocation of Orphan Drug status for Indivior PLC’s (OTCPK:INVVY) Sublocade (buprenorphine extended-release) injection, approved in the U.S. on November 30, 2017 for the treatment of moderate-to-severe opioid addiction.
The action clears the way for full U.S. approval of Braeburn’s Brixadi (buprenorphine) effective December 1, 2020, instead of five years later as afforded by Orphan Drug status (Sublocade has a three-year period of clinical exclusivity).
The FDA tentatively approved Brixadi in December 2018. It filed the Citizen Petition in April of this year.
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Recro Pharma EPS misses by $0.03, beats on revenue

Recro Pharma (NASDAQ:REPH): Q3 GAAP EPS of -$0.19 misses by $0.03.
Revenue of $25.26M (+38.2% Y/Y) beats by $4.67M.
Press Release
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Sutro Biopharma EPS beats by $0.09, beats on revenue

Sutro Biopharma (NASDAQ:STRO): Q3 GAAP EPS of -$0.56 beats by $0.09.
Revenue of $12.28M (+56.6% Y/Y) beats by $2.41M.
Press Release
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Medifast down 29% premarket on Q3 miss and guidance cut

Medifast (NYSE:MED) is down 29% premarket on light volume on the heels of its Q3 report released after the close yesterday. Highlights:
Revenue: $190.1M (+36.5%).
Net income: $15.9M (+15.4%); EPS: $1.32 (+15.8%).
Q4 guidance: Revenue: $157M – 167M; EPS: $1.03 – 1.13.
2019 guidance: Revenue: $700M – 710M from $730M – 750M; EPS: $5.80 – 5.90 from $6.75 – 6.95. Guidance revised due to “short-term challenges.”
Previously: Medifast EPS misses by $0.01, misses on revenue (Nov. 7)
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Iovance up 12% premarket on positive lifileucel data

Iovance Biotherapeutics (NASDAQ:IOVA) is up 12% premarket on light volume in reaction to new data from a Phase 2 clinical trial, C-144-01, evaluating lifileucel, an autologous adoptive cell transfer therapy, in metastatic melanoma patients. The results were presented at the SITC Annual Meeting in Maryland.
Data from Cohort 2, consisting of patients who received an average of 3.3 prior lines of therapy, showed a 35% objective response rate (ORR) as determined by an independent review committee. Median duration of response (DOR) had not been reached at data cutoff (median follow-up of 12.8 months as assessed by the investigator).
The estimated primary completion date of the study is March 2020.
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