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Monday, December 9, 2019

Analyst action, Dec. 9

89bio (NASDAQ:ETNB) initiated with Neutral rating and $33 (15% upside) price target at BofA Merrill Lynch, Outperform with a $60 target of Oppenheimer and Outperform with a $36 target at RBC.
Zymeworks (NYSE:ZYME) initiated with Neutral rating and $43 (3% upside) price target at JPMorgan.
Fate Therapeutics (NASDAQ:FATE) upgraded to Overweight with a $24 (76% upside) price target at Well Fargo. Shares up 31% premarket on positive data presented as ASH in Orlando.
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UnitedHealth to Buy Diplomat at 31% Discount to Friday’s Closing Price

UnitedHealth Group said on Monday said it agreed to buy Diplomat Pharmacy for $4.00 a share in cash, a roughly 31% discount to Friday’s closing price.
Shares of Diplomat, a Flint, Mich., provider of specialty pharmacy and infusion services, closed Friday at $5.81.
UnitedHealth, a Minnetonka, Minn., health insurer, said it will combine Diplomat with OptumRx, the pharmacy-care-services business of its Optum health-services unit.
UnitedHealth said the combination will support improved health outcomes and reduced prescription-drug costs while helping lower the overall total cost of care.
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Roche Extends Tender Offer for Spark Therapeutics

Roche Holding AG said Monday that it has extended the offer period for its planned takeover of biotechnology company Spark Therapeutics to Dec. 16.
Swiss pharmaceutical company Roche said the offer was extended to provide additional time for the U.S. Federal Trade Commission and the U.K. Competition and Markets Authority to complete their reviews of the pending acquisition.
The period for Roche’s offer of $114.50 per share has been extended several times and was set to expire on Dec. 10.
As of Dec. 6, around 14.9% of Spark’s outstanding shares had been tendered, according to Roche.
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Marinus updates on ganaxolone in epilepsy

Marinus Pharmaceuticals (NASDAQ:MRNS) announces clinical and regulatory updates for its orphan seizure programs in tuberous sclerosis complex (TSC), CDKL5 deficiency disorder (CDD) and PCDH19-related epilepsy (PCDH19-RE).
The company intends to initiate a Phase 2 trial evaluating the safety and tolerability of ganaxolone in TSC in H1 2020. The study will enroll approx. 20-40 patients ages 2 to 65. The primary endpoint is percent change in 28-day primary seizure frequency through the end of the 12-week treatment period relative to the 4-week baseline period.
The European Medicines Agency has granted orphan drug designation for ganaxolone for the treatment of CDD.
Topline data from Phase 3 Marigold study evaluating the use of oral ganaxolone in children and young adults with CDD is expected in Q3 2020.
International site initiation and enrollment is continuing in Phase 3 Violet Study, evaluating oral ganaxolone in children with PCDH19-RE. The study will enroll up to 70 patients between the ages of 1 and 17. The Company remains on-track to report top-line data in 2021.
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Kamada inks binding term sheet for hyper-immune globulin product

Kamada (NASDAQ:KMDA) has entered into a binding term sheet for a 12-year contract manufacturing agreement with an undisclosed partner to manufacture FDA approved and commercialized specialty hyper-immune globulin product.
The company expects to commence commercial manufacturing of the product in early 2023.
Based on the current market sales volume, the new product is estimated to add approx. $8M to $10M in annual revenues.
Kamada will continue to manufacture and sell KEDRAB as well as our other proprietary products.
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KalVista’s KVD001 flunks mid-stage DME study

Thinly traded micro cap KalVista Pharmaceuticals (NASDAQ:KALV) slumps 20% premarket on average volume in reaction to unsuccessful results from a Phase 2 clinical trial evaluating KVD001 in diabetic macular edema (DME) patients who failed to respond adequately to previous anti-VEGF therapy.
KVD001, a small molecule plasma kallikrein inhibitor administered via intravitreal injection, failed to sufficiently separate from sham (placebo) as measured by best corrected visual acuity (BCVA) at week 16, the primary endpoint. Specifically, the relative effect of KVD001 on BCVA was +1.5 letters for the 3μg dose (p=0.465) and +2.6 letters (p=0.223) for the 6μg dose, both well short of statistical significance. No statistically valid differences were noted in key secondary endpoints either.
On a positive note, KVD001 showed protection against vision loss. 32.5% of participants in the treatment group experienced a reduction in vision compared to 54.5% in the sham group (p=0.042).
Merck (NYSE:MRK) has an option to acquire the rights to KVD001 under a 2017 agreement.
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ArQule up 101% premarket on Merck bid

Merck (NYSE:MRK) has agreed to acquire ArQule (NASDAQ:ARQL) for $20 per share in cash, valuing the transaction at $2.7B.
ArQule’s lead candidate is ARQ 531, an oral BTK inhibitor in Phase 2 development for B-cell malignancies.
Shares up 101% premarket on robust volume.
Update: ARQL will host an investor event this morning starting at 8:00 am ET to discuss ARQ 531 data being presented at ASH. A conference call and webcast will start at 8:15 am ET. The ASH presentation of Phase 1 results is scheduled for today at 6:00 pm ET.
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