BioShares Biotechnology Clinical Trials (BBC): $18.67, -$0.20, -35.7% YTD
BioShares Biotechnology Products (BBP): $33.22, -$0.54, +7.8% YTD
Wall Street looked set to open little changed on Thursday, a day after the S&P 500 index suffered its biggest fall in two months, putting a damper on a post-election rally. A report showed the number of Americans applying for jobless claims fell by 10,000 to 265,000 last week, indicating sustained strength in the labor market.
Aurinia Pharmaceuticals announced that it has closed its previously announced US$28.75 million financing (including US$3.75 million pursuant to an exercise of the underwriter’s over-allotment option), for the sale of 12,777,775 units (“Units”) of the Company at a price of US$2.25 per Unit. Each Unit consists of one common share of the Company (a "Share") and one-half of one common share purchase warrant (each whole warrant, a "Warrant"). Each Warrant entitles the holder thereof to purchase one Share at the exercise price of US$3.00 per Share for a period of 5 years after the closing of the offering.
Cempra announced that the company has received a CRL from the FDA relating to the company’s NDAs for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults. The CRL states that the FDA cannot approve the NDAs in their present form and notes that additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies are required before the NDAs may be approved. The FDA did not request any further information on solithromycin efficacy for CABP in the CRL.
Aptose Biosciences provided an update on the development of APTO-253, its investigational compound for acute myeloid leukemia (AML). The company has successfully manufactured multiple batches of a new drug product formulation for APTO-253, including a batch that has been stable and soluble for over six months. However, Aptose will have to repeat the production of the fourth batch, a 40L batch that was the intended clinical supply, because of a correctable engineering design incompatibility during the filling process. Aptose expects the batch records and release specifications from such a new batch, along with the stability and sterility data, to be provided to the FDA during the first quarter of 2017.
Mylan announced the U.S. launch of Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL), packaged in 100 mg PE*/2 mL, and 500 mg PE*/10 mL single-use vials, a generic version of Pfizer‘s Cerebyx Injection. Mylan received final approval from the FDA for its ANDA for this product, for the treatment of certain types of severe seizures.
Mylan announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg. Mylan’s product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Zovia 1/50E-28 Tablets (Watson). Mylan’s subsidiary, Jai Pharma Limited, received final approval from the FDA for its ANDA for this product, which is indicated for use by women to prevent pregnancy.
Corbus Pharmaceuticals Holdings announced that it has completed its Phase II study evaluating JBT-101 ("Resunab") for the treatment of cystic fibrosis ("CF"). JBT-101, the Company’s novel synthetic oral endocannabinoid-mimetic drug, is designed to resolve chronic inflammation and halt fibrosis. Corbus expects to report topline data from this study in the first quarter of 2017.
On December 27, 2016, Imprimis Pharmaceuticals entered into a third amendment to the Loan and Security Agreement dated May 11, 2015, and previously amended on October 20, 2015 and again on January 22, 2016, with IMMY Funding, an affiliate of Life Sciences Alternative Funding, as lender and collateral agent. Concurrently with entering into and related to the Amendment, the Company and the Lender also entered into an Exchange and Discharge Agreement. The Amendment and Exchange Agreement, among other things, primarily allowed for the Company and the Lender to exchange a $3,000,000 principal balance convertible note dated January 22, 2016 issued by the Company to the Lender, for a $3,000,000 term loan. The Term B Loan was issued in exchange for, and not funded separately, cancellation and discharge of all indebtedness related to the Convertible Note. Terms, conditions and security interests of the Term B Loan are substantially equal to those of the Loan Agreement. The Amendment also amended certain terms and definitions associated with prepayment, payment schedule, amortization periods and defined the outstanding principal amounts due to the Lender under the Loan Agreement and Term B Loan, including any interest that has been paid in kind of the principal balance, in aggregate, as $13,332,255. No other amounts are due to the Lender.
Prima BioMed announced interim data for its TACTI-mel (Two ACTive Immunotherapeutics in melanoma) clinical trial program for IMP321 in unresectable or metastatic melanoma patients. The Database Safety Monitoring Board (DSMB) confirmed that IMP321 is safe and well tolerated at the first dose level when used in combination with a PD-1 blocking antibody and dose escalation can continue as planned.
Galectin Therapeutics announced it has recently completed a private placement of its common stock, raising $3,000,000 in new funding. In a separate transaction, the Company also closed an additional sale of its Series B-3 preferred stock resulting in $1,008,000 of additional new proceeds.
Strongbridge Biopharma announced that it closed its previously announced $35 million equity financing and $40 million credit facility transactions.
Following Anthera’s news that SOLUTION failed to achieve its noninferiority endpoint by ITT but was successful per protocol, Jefferies analyst Matthew Andrews downgraded the stock to “hold” from “buy” and decreased his price target to $1 from $5; HC Wainwright analyst Andrew Fein decreased his price target to $3 from $10; Piper Jaffray analyst Edward Tenthoff decreased his price target to $1.35 from $7; Citi analyst Yigal Nochomovitz downgraded the stock to “neutral” from “buy” and decreased his price target to $0.90 from $6.
Leerink analyst Geoffrey Porges increased his price target of Biogen to $370 from $368, citing pricing services were updated to include disclosure that Biogen/Ionis’ Spinraza (nusinersen) had listed a wholesale acquisition cost of $125,000 per dose.
Northland Securities analyst Robert Breza initiated coverage of Intrexon with an “outperform” rating and $40 price target, citing Intrexon’s DNA analysis and engineering platform addresses a large market opportunity where biology and technology meet, while its unique business model inherently reduces risk from a single application, allowing for a more efficient capital allocation model.