Momenta: Impending Approval Provides Price Support With Excellent Upside Potential
Buddy Lyons • 12 Comments
Buddy Lyons • 12 Comments
Oct. 22, 2014, 11:59 AM
- Momenta Pharmaceuticals (MNTA -0.9%) will report Q3 results on November 5 before the open. The conference call will begin at 10:00 am ET.
- Consensus view is a loss of ($0.43) per share on revenues of $13M.
Oct. 15, 2014, 4:13 AM
- The Supreme Court is due to hear oral arguments today over a patent for Teva's (NYSE:TEVA) top-selling multiple sclerosis drug Copaxone, which accounts for 50% of its profit.
- The patent was due to expire in September 2015, although in July 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid. Copaxone has no IP protection at the moment.
- Two consortia are developing generic versions of Copaxone, with one involving Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), and the other Mylan (NASDAQ:MYL) and Natco. The companies risk having to pay Teva hundreds of millions of dollars if they introduce Copaxone and then lose in the Supreme Court.
Jul. 31, 2014, 10:44 AM
- Momenta Pharmaceuticals (MNTA -3.5%) Q2 results: Collaboration revenue: $11.0M (+151.1%); Operating Expenses: $37.3M (+11.3%); Operating Loss: ($26.4M) (+9.3%); Net Loss: ($26.2M) (+9.0%); Loss Per Share: ($0.51) (+5.3%); Quick Assets: $202.3M (-17.7%).
- 2014 Guidance: Operating expenses: $28M - 30M per quarter; cash burn: ~$26M per quarter.
Jul. 31, 2014, 8:11 AM
- Momenta Pharmaceuticals (NASDAQ:MNTA): Q2 EPS of -$0.51 misses by $0.07.
- Revenue of $10.95M (+151.1% Y/Y) misses by $0.27M.
Jul. 3, 2014, 8:28 AM
- In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
- Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
- One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
- Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
Jun. 5, 2014, 9:52 AM
- The FDA designates Momenta Pharmaceuticals' (MNTA +2.1%) oncology drug candidate necuparanib an Orphan Drug for the treatment of pancreatic cancer. Necuparanib is a heparan sulfate mimetic, derived from unfractionated heparin. It retains its antitumor properties while minimizing its anticoagulant activity.
- The company expects to complete part A of its Phase 1/2 study of necuparanib in combination with Abraxane and gemcitabine in the next several months. Phase 2 will commence in 2H 2014.
May 15, 2014, 3:51 PM
- Shares of Momenta Pharmaceuticals (MNTA +11.3%) are up on slightly higher volume in response to a federal judge's tossing of Teva's (TEVA -0.9%) lawsuit accusing the FDA of acting improperly by not demanding additional testing of generic forms of Copaxone before clearing them for marketing.
- Teva gets a "A" for effort in trying to stop competitors from selling their generic offerings especially since it is usually on the other side of the aisle. The U.S. Supreme Court has yet to rule on its patent infringement case vs Mylan and Sandoz.
May 15, 2014, 12:46 PM
May 6, 2014, 8:10 AM
- Momenta Pharmaceuticals (MNTA): Q1 EPS of -$0.53 in-line.
- Revenue of $10.8M (+42.1% Y/Y) beats by $2.39M.
May 5, 2014, 5:30 PM
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Apr. 21, 2014, 9:13 AM
Apr. 15, 2014, 8:09 AM
- Two teams of generic Copaxone makers, Sandoz/Momenta and Mylan/Natco ask the U.S. Supreme Court to allow a lower court ruling giving them the green light to market their offerings to take effect until it considers Teva's (TEVA) appeal in October.
- The companies state that Teva failed to show that it would suffer "irreparable harm" if the stay was not issued.
- The Court could announce its decision at any time.
- A ruling on the case might not happen until mid-2015.
- (NVS) (MYL) (MNTA)
Apr. 7, 2014, 1:36 PM
- Lawyers for Teva Pharmaceutical Industries (TEVA -2%) ask the Supreme Court to stop a lower court ruling allowing generic Copaxone makers to launch offerings as early as May.
- The Court accepted the case on March 31 but will not hear oral arguments until October and a ruling might not happen until mid-2015.
- Teva believes it will suffer "irreparable harm" if other generics are allowed to market.
Mar. 31, 2014, 12:47 PM
Mar. 31, 2014, 11:05 AM
- Shares of generic drug maker Momenta Pharmaceuticals (MNTA -11.4%) are down in early trading after the Supreme Court agrees to hear Teva's (TEVA +4.7%) appeal of a lower court's ruling invalidating its Copaxone patents.
- Without a reversal the product's exclusivity expires May 24.
Feb. 10, 2014, 8:02 AM
- Momenta Pharmaceuticals, Inc. (MNTA): Q4 EPS of $-0.59 misses by $0.14.
- Revenue of $12.75M (+0.2% Y/Y) beats by $4.22M.
Momenta Pharmaceuticals, Inc. is a biotechnology company, engages in the structural analysis of complex mixture drugs. The company focuses on discovering and developing medicines in three product areas: complex generics, biosimilars and novel therapeutics for oncology and autoimmune disease. The... More
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